CompletedPhase 3

Seroquel- Agitation Associated With Dementia

333 participantsStarted 2002-09

Plain-language summary

The purpose of this study is to determine how safe and effective Seroquel (quetiapine fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the treatment of agitation symptoms in nursing home or assisted care residents. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Who can participate

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must have a diagnosis of dementia compatible with probable or possible Alzheimer's disease (AD) * Subjects exhibit inappropriate verbal, vocal, or motor activity that requires treatment with an antipsychotic medication in addition to or beyond behavioural modification therapy * Subject must have a score of at least 14 on the PANSS Exclusion Criteria: * Current or past symptoms for schizophrenia, schizoaffective disorder, or bipolar disorder * Symptoms of agitation that are caused by another general medical condition or direct physiological effects of a substance * Failure to respond on 2 occasions to an adequate regimen of atypical antipsychotic medications for the treatment of agitation and/or aggression

What they're measuring

To assess the efficacy of 2 fixed doses of quetiapine compared with placebo

Timeframe: Twice weekly

Trial details

NCT IDNCT00621647

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-11

View on ClinicalTrials.gov More Alzheimer's Disease trials